Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors

针对不同种族和地域的癌症幸存者增加基于指南的遗传咨询的干预措施的比较有效性

• 批准号: 9215545
• 负责人: Anita Y. Kinney
• 金额: $ 62.92万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-22 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9215545
• 关键词: Address; Adherence; Adoption; Affective; Age; Attitude; Awareness; BRCA1 gene; BRCA2 gene; Belief; Breast; Cancer Center; Cancer Etiology; Cancer Survivor; Caring; Cognitive; Colorado; Communication; Conflict (Psychology); Counseling; Data; Decision Making; Diagnosis; Disease; Distress; Early Diagnosis; Effectiveness of Interventions; Enrollment; Ensure; Ethnic Origin; Excision; Family; Family member; Female; Fright; Generic Drugs; Genes; Genetic Counseling; Genetic Services; Genetic screening method; Genomics; Geography; Goals; Guidelines; Health; Health Personnel; Healthcare; Hereditary Breast Carcinoma; High Risk Woman; High-Risk Cancer; Hispanics; Improve Access; Individual; Individual Differences; Intervention; Intervention Studies; Knowledge; Life; Malignant Neoplasms; Malignant neoplasm of ovary; Measures; Mediating; Medical Genetics; Morbidity - disease rate; Motivation; Mutation; New Mexico; Not Hispanic or Latino; Outcome; Ovarian; Participant; Persons; Policy Maker; Population; Population Heterogeneity; Process; Provider; Public Health; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Registries; Regrets; Risk; Risk Assessment; Risk Reduction; Rural; Savings; Second Primary Cancers; Services; Specific qualifier value; Stress; Surveys; System; Telephone; Testing; Translations; Uncertainty; Underserved Population; Woman; Work; arm; base; behavior change; cancer care; cancer education; cancer genetics; cancer health disparity; cancer prevention; cancer risk; care delivery; clinical practice; comparative effectiveness; compare effectiveness; cost; cost effectiveness; demographics; disparity reduction; economic evaluation; empowerment; evidence base; follow-up; genetic risk assessment; health disparity; health literacy; high risk; improved; innovation; intervention effect; lifestyle factors; malignant breast neoplasm; medically underserved; medically underserved population; mortality disparity; neoplasm registry; peritoneal cancer; precision medicine; preference; prevent; primary outcome; public health intervention; randomized trial; rural dwellers; social; successful intervention; survivorship; telehealth; three-arm study; treatment as usual; uptake

Genetic counseling or Cancer Genetic Risk Assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) is an evidence-based precision medicine strategy that facilitates informed decision making about effective health management options. Identification of individuals at increased risk of HBOC is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. Although national guidelines for CGRA and genetic testing have been available for two decades, only one-third or less of high-risk women have accessed these services. The optimal risk assessment strategy starts with an individual with an HBOC-related cancer. Widespread dissemination and adoption of national guidelines for informed decision-making and promoting CGRA is needed to achieve a population-level reduction in cancer morbidity, mortality and disparities. Thus, it is important to promote access to CGRA, particularly in medically underserved populations. The proposed Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project seeks to address this important translational gap by developing and implementing strategies to promote guideline-based care in the Rocky Mountain region where there are distinguishable disparities in CGRA utilization by ethnicity and geography. Remarkably, few intervention studies have been conducted to address the regional and national translational gap in CGRA utilization for these diverse populations, underscoring our study's high impact and innovative public health intervention delivery approach. The GRACE Project is guided by evidenced-based behavior change counseling strategies to promote risk-based care delivery and reduce disparities that consider individual, cultural, social and system-level factors. The study's primary aim is to test the comparative effectiveness of mailed targeted print (TP) vs. TP plus a telephone-based tailored counseling and navigation intervention (TCN) vs. usual care (UC) to increase guideline-based CGRA for HBOC. We will oversample Hispanics and rural dwellers and enroll 1206 high-risk female cancer survivors. Women will be recruited through the Colorado and New Mexico cancer registries and meet the criteria for a CGRA referral. Enrollees will be randomized to one of 3 study arms and complete baseline, 1-month, 6-month and 12-month surveys. Specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored (TPC) intervention vs. usual care (UC) on CGRA utilization 6 months (primary outcome) after the intervention and at 12 months, after removal of key access barriers; 2) compare the effectiveness of the interventions on genetic testing utilization; 3) examine potential underlying theoretical mediating and moderating mechanisms that will further specify and elucidate significant intervention effects; and 4) compare the cost effectiveness of the interventions vs. usual care, for utilization of CGRA services. If effective, either or both interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination.

遗传咨询或癌症遗传风险评估（CGRA）用于遗传性乳腺癌和卵巢癌 （HBOC）是一种基于证据的精确医学策略，可促进有关有关的知情决策 有效的健康管理选择。识别以HBOC风险增加的个体对 癌症幸存者及其家人从预防癌症，早期检测中的生物医学进步中受益 治疗和生存。尽管国家CGRA和基因检测指南已可用于 二十年来，只有三分之一或更少的高风险妇女获得了这些服务。最佳风险 评估策略始于患有HBOC相关癌症的个体。广泛的传播和 需要采用国家准则来实现知情决策和促进CGRA以实现 癌症发病率，死亡率和差异的人口水平降低。因此，促进访问很重要 到CGRA，尤其是在医学欠缺的人群中。提出的遗传风险评估 通过 制定和实施策略，以促进落基山地区的基于准则的护理 通过种族和地理，CGRA利用率存在明显的差异。值得注意的是，很少 已经进行了干预研究，以解决CGRA的区域和国家翻译差距 这些不同人群的利用，强调了我们研究的高影响力和创新的公共卫生 干预交付方法。恩典项目以基于证据的行为变更咨询为指导 促进基于风险的护理交付并减少考虑个人，文化，社会的差异的策略 和系统级因素。该研究的主要目的是测试针对邮寄的比较有效性 印刷（TP）与TP以及基于电话的量身定制咨询和导航干预（TCN）与通常的护理 （UC）增加基于指南的HBOC的CGRA。我们将超出西班牙裔和农村居民和注册 1206个高危女性癌症幸存者。妇女将通过科罗拉多州和新墨西哥州癌症招募 注册表并符合CGRA推荐的标准。参与者将被随机分为3个研究组之一，并且 完整的基线，1个月，6个月和12个月的调查。具体目的是：1）比较 针对性干预（TP）与量身定制的（TPC）干预的有效性与CGRA的常规护理（UC） 干预后的6个月（主要结果）和12个月的利用率（主要结果），拆除关键访问 障碍； 2）比较干预措施对基因测试利用的有效性； 3）检查潜力 基本的理论中介和调节机制将进一步指定并阐明重要 干预效果； 4）比较干预措施与通常护理的成本效益，以利用 CGRA服务。如果有效，则两种干预措施都有可能达到大量高风险 家庭并通过广泛的传播减少差异。